Heart FailurePhase 3NCT01284400
Home-based Disease Management Program to Improve Clinical Outcomes in Patients With Heart Failure
A Phase 3 study testing Home-based disease management in people with Heart Failure, run by Japanese Heart Failure Outpatient Disease Management Evaluation Investigators.
Trial summary
Although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure (HF), no study has focused on psychological status as an outcome of disease management in patients with HF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Home-based disease management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 18 years
Who cannot join
- End-stage HF defined as requiring mechanical support or continues intravenous inotropic support
- A serious life-threatening illness with a life-expectancy of <6 months Within the past 3 months
- Cognitive dysfunction
- Substance abuse or psychotic disorder
- Managed by visiting nursing
- Long distance between patients' home and hospital
About this study
Official title: The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE)
Although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure (HF), no study has focused on psychological status as an outcome of disease management in patients with HF. Disease management could lead to the reduction of psychological distress, thus improving the self-care ability and adherence of patients with HF. In addition, very little information is available on the effectiveness of disease management programs in areas other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the efficacy of home-based disease management programs compared with usual care in improving psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.
- Conditions
- Heart Failure
- Being tested
- Home-based disease management
- Keywords
- heart failure, disease management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based disease managementOther
Symptom monitoring, comprehensive advice, and counseling at home by nurses, as well as telephone follow-up by nurses
| Study group | Role | What they receive |
|---|---|---|
| Disease management | Experimental | Not described Receives: Other: Home-based disease management |
| Usual treatment and care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial status (depression, anxiety)
Measured: up to 12 months
Secondary outcomes (5)
Death
Measured: up to 12 months
Readmission due to heart failure
Measured: up to 12 months
Hospital admission
Measured: up to 12 months
Quality of life
Measured: up to 12 months
Physical activity
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japanese Heart Failure Outpatient Disease Management Evaluation Investigators
- Sponsor type
- Research network
- Investigators
- Hiroyuki Tsutsui, MD, PhD, Study chair, Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284400
- Sponsor's protocol ID
- J-HOMECARE
- Other IDs
- UMIN000000565
- Status last verified
- May 2011
- First submitted
- 25 Jan 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsuchihashi-Makaya M, Matsuo H, Kakinoki S, Takechi S, Kinugawa S, Tsutsui H; J-HOMECARE Investigators. Home-based disease management program to improve psychological status in patients with heart failure in Japan. Circ J. 2013;77(4):926-33. doi: 10.1253/circj.cj-13-0115. Epub 2013 Mar 15.
PubMed 23502992Tsuchihashi-Makaya M, Matsuo H, Kakinoki S, Takechi S, Tsutsui H; J-HOMECARE Investigators. Rationale and design of the Japanese heart failure outpatients disease management and cardiac evaluation (J-HOMECARE). J Cardiol. 2011 Sep;58(2):165-72. doi: 10.1016/j.jjcc.2011.04.004.
PubMed 21640556
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE)
- ClinicalTrials.gov ID
- NCT01284400
- Acronym / sponsor ID
- J-HOMECARE
- Conditions
- Heart Failure
- Keywords
- heart failure, disease management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Japanese Heart Failure Outpatient Disease Management Evaluation InvestigatorsResearch network
- Study start
- Jan 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure (HF), no study has focused on psychological status as an outcome of disease management in patients with HF. Disease management could lead to the reduction of psychological distress, thus improving the self-care ability and adherence of patients with HF. In addition, very little information is available on the effectiveness of disease management programs in areas other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the efficacy of home-based disease management programs compared with usual care in improving psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease management | Experimental | Other: Home-based disease management |
| Usual treatment and care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age ≥ 18 years
Key exclusion criteria (6 listed)
- End-stage HF defined as requiring mechanical support or continues intravenous inotropic support
- A serious life-threatening illness with a life-expectancy of <6 months Within the past 3 months
- Cognitive dysfunction
- Substance abuse or psychotic disorder
- Managed by visiting nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based disease managementSymptom monitoring, comprehensive advice, and counseling at home by nurses, as well as telephone follow-up by nurses | Other | Disease management |
Primary outcome
Psychosocial status (depression, anxiety)
Time frame: up to 12 months
5 secondary outcomes
Death
Time frame: up to 12 months
Readmission due to heart failure
Time frame: up to 12 months
Hospital admission
Time frame: up to 12 months
Quality of life
Time frame: up to 12 months
Physical activity
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
- Derived from this study: PubMed 23502992Tsuchihashi-Makaya M, Matsuo H, Kakinoki S, Takechi S, Kinugawa S, Tsutsui H; J-HOMECARE Investigators. Home-based disease management program to improve psychological status in patients with heart failure in Japan. Circ J. 2013;77(4):926-33. doi: 10.1253/circj.cj-13-0115. Epub 2013 Mar 15.
- Derived from this study: PubMed 21640556Tsuchihashi-Makaya M, Matsuo H, Kakinoki S, Takechi S, Tsutsui H; J-HOMECARE Investigators. Rationale and design of the Japanese heart failure outpatients disease management and cardiac evaluation (J-HOMECARE). J Cardiol. 2011 Sep;58(2):165-72. doi: 10.1016/j.jjcc.2011.04.004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroyuki Tsutsui, MD, PhD study chair
Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home-based disease management in people with Heart Failure, run by Japanese Heart Failure Outpatient Disease Management Evaluation Investigators.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial status (depression, anxiety) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01284400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011; AzTrials last refreshed its copy on 5 Nov 2026.